BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 23678282 · Received December 1, 2025

    Report

    Report Number
    8010762-2025-0000528
    Event Type
    Malfunction
    Date Received
    December 1, 2025
    Date of Event
    November 12, 2025
    Report Date
    December 16, 2025
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    KFM
    UDI-DI
    04037691718910
    PMA / PMN Number
    K991864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING. FURTHER INFORMATION HAS BEEN REQUESTED BUT HAS NOT YET BEEN RECEIVED. A FOLLOW UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. NOTE: THIS EVENT OCCURRED ON THE CHINESE MARKET. IT IS A SIGNIFICANTLY SIMILAR DEVICE TO "BASE UNIT, ROTAFLOW CONSOLE¿ WHICH IS SOLD IN THE USA UNDER PREMARKET SUBMISSION NUMBER: K991864. FOR SECTION D4 ALL AVAILABLE IDENTIFYING INFORMATION IS FOR THE OUT OF THE US DEVICE, SUBJECTED TO THIS REPORT. THEREFORE, NO GUDID INFORMATION EXISTS. FURTHERMORE, UDI INFORMATION (PRIMARY DI NUMBER) PROVIDED IN D4 IS FOR ROTAFLOW CONSOLE WITH CATALOG NUMBER: 701046405.

    Additional Manufacturer Narrative · 0

    THE EVENT OCCURRED IN CHINA. IT WAS REPORTED THAT THE ERROR MESSAGE ¿HEAD ERROR¿ OCCURRED ON THE ROTAFLOW CONSOLE. THE FAILURE OCCURRED DURING USE AND THE DEVICE WAS REPLACED IMMEDIATELY UPON OCCURRENCE. NO HARM TO ANY PERSON HAS BEEN REPORTED. THE REPORTED ¿HEAD ERROR¿ COULD LEAD TO A PUMP STOP DURING USE, THEREFORE A REPORT IS REQUIRED. THE PATIENT DATA WAS NOT SHARED BY CUSTOMER. A GETINGE FIELD SERVICE TECHNICIAN INVESTIGATED THE AFFECTED ROTAFLOW CONSOLE (RFC) WITH S/N (B)(6) AND THE ROTAFLOW DRIVE (RFD) WITH S/N (B)(6). THE REPORTED "HEAD ERROR" COULD NOT BE REPRODUCED DURING STARTUP TESTING, AND SIMULATED OPERATION PROCEEDED NORMALLY. IT IS RECOMMENDED TO PERFORM A PREVENTATIVE REPLACEMENT OF THE CORRESPONDING COMPONENTS BEFORE RESUMING USE. NO PARTS WERE REPLACED YET, AS THE CUSTOMER HAS NOT ACCEPTED THE PREVENTATIVE PART REPLACEMENT. THE DEVICE IS CURRENTLY OUT OF SERVICE. BASED ON THESE INVESTIGATION RESULTS THE REPORTED FAILURE "HEAD ERROR" COULD NOT BE CONFIRMED. HOWEVER, THE MOST PROBABLE ROOT CAUSE FOR THE REPORTED FAILURE "HEAD ERROR" COULD BE DETERMINED AS: 1. THE HEAD ERROR FOLLOWS THE SIG ERROR. WHEN THE ULTRASONIC CREAM IS APPLIED (DUE TO THE SIG ERROR) TO THE FLOW BUBBLE SENSOR AND THE DISPOSABLE IS MOVED CLOSE TO THE ROTA FLOW DRIVE, THE MAGNETS IN THE CENTRIFUGAL PUMP INTERFERE WITH THE SENSORS IN THE ROTA FLOW DRIVE. THIS ERROR CAN BE OVERWRITTEN BY RESTARTING THE ROTA FLOW CONSOLE. 2. IF THE RPM / LPM IS SET TO ZERO AND THE DRIVE AS WELL AS THE INSERTED CENTRIFUGAL PUMP IS SHAKEN THIS CAUSES MAGNETIC UNCOUPLING OF THE CENTRIFUGAL PUMP AND THUS LEADS TO THE HEAD ERROR. THIS ERROR CAN BE OVERWRITTEN BY RESTARTING THE ROTA FLOW CONSOLE. ROTAFLOW CONSOLE: THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED ON (B)(6) 2025 FOR THE PERIOD OF 2020-10-28 TO 2025-11-18. IT DOES NOT SHOW ANY NON-CONFORMITY IN REGARD TO THE REPORTED PRODUCT AND FAILURE. THERE IS NO INDICATION THAT MANUFACTURING ISSUES OCCURRED DURING THIS TIME, THUS PRODUCTION RELATED INFLUENCES ARE UNLIKELY. THE ROTAFLOW CONSOLE WITH S/N (B)(6) WAS PRODUCED IN (B)(6) 2020. ROTAFLOW DRIVE: THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED ON (B)(6) 2025 FOR THE PERIOD OF 2020-10-14 TO 2025-11-18. IT DOES NOT SHOW ANY NON-CONFORMITY IN REGARD TO THE REPORTED PRODUCT AND FAILURE. THERE IS NO INDICATION THAT MANUFACTURING ISSUES OCCURRED DURING THIS TIME, THUS PRODUCTION RELATED INFLUENCES ARE UNLIKELY. THE ROTAFLOW DRIVE WITH S/N (B)(6) WAS PRODUCED IN (B)(6) 2020. IN ADDITION, A REVIEW FOR POTENTIAL FIELD ACTIONS AND CAPAS RELATED TO THE FAILURE AND PRODUCT IN THIS COMPLAINT WAS PERFORMED. THIS COMPLAINT IS NOT IN SCOPE OF ANY ONGOING FIELD ACTIONS AND/OR CAPAS. FOR THE AFFECTED SERIAL NUMBERS WITHIN THE TIMEFRAME OF THE SEARCH NO ADDITIONAL COMPLAINT WAS FOUND FOR THE SAME ISSUE. IN ORDER TO AVOID REOCCURRENCE OF THE REPORTED FAILURE "HEAD ERROR", IT IS NECESSARY TO FOLLOW THE CHAPTER IN THE INSTRUCTION FOR USE HEART-LUNG SUPPORT SYSTEM ROTAFLOW SYSTEM/ 4.4 / EN / 15. CHAPTER 4.1.3: SWITCH OFF THE ROTAFLOW CONSOLE ON/OFF SWITCH BEFORE CONNECTING THE ROTAFLOW DRIVE TO OR DISCONNECTING IT FROM THE ROTAFLOW CONSOLE. OTHERWISE, THE ROTAFLOW CONSOLE MAY BE DAMAGED. CHAPTER 2.2.3. TAKE DAMAGED DEVICES OUT OF SERVICE IMMEDIATELY AND HAVE THEM TESTED BY THE AUTHORIZED SERVICE PERSONNEL. IT IS ALSO NECESSARY TO FOLLOW THE CHAPTER IN THE SERVICE MANUAL FOR USE HEART-LUNG SUPPORT SYSTEM ROTAFLOW SYSTEM/ EN / 03 CHAPTER 1.7 SERVICE-RELATED WORK ON A DEVICE MAY ONLY BE CARRIED OUT BY SERVICE TECHNICIANS WHO HAVE BEEN TRAINED AND INSTRUCTED AND CERTIFIED BY GETINGE. SERVICE-RELATED WORK ON A DEVICE CARRIED OUT BY UNQUALIFIED SERVICE TECHNICIANS' MAY LED TO INJURY OF THE SERVICE TECHNICIAN, PATIENT OR OTHER PERSONS OR MAY LED TO DEVICE DAMAGE. CHAPTER 1.10 A REPAIR IS CARRIED OUT FOR MAINTENANCE AFTER DAMAGE OR MALFUNCTION OF A ROTAFLOW SYSTEM. THE OCCURRENCE RATE WAS CALCULATED FOR THE REPORTED ISSUE AND IT WAS DETERMINED THAT THIS IS NOT A SYSTEMIC ISSUE. THEREFORE, NO REMEDIAL ACTION IS REQUIRED. THE OCCURRENCE RATE RELATED TO THE REPORTED ISSUE IS CURRENTLY BEING MONITORED AS PART OF MAQUET CARDIOPULMONARY¿ S TRENDING PROGRAM AND ADDITIONAL INVESTIGATIONS OR CORRECTIONS WILL BE IMPLEMENTED IN CASE OF ADVERSE TRENDING.

    Description of Event or Problem · 0

    THE EVENT OCCURRED IN CHINA. IT WAS REPORTED THAT THE ERROR MESSAGE ¿HEAD ERROR¿ OCCURRED ON THE ROTAFLOW CONSOLE. THE FAILURE OCCURRED DURING USE AND THE DEVICE WAS REPLACED IMMEDIATELY UPON OCCURRENCE. NO HARM TO ANY PERSON HAS BEEN REPORTED. THE REPORTED ¿HEAD ERROR¿ COULD LEAD TO A PUMP STOP DURING USE, THEREFORE A REPORT IS REQUIRED. COMPLAINT ID: (B)(4).

    Description of Event or Problem · 0

    COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2727772 HEART LUNG MACHINE PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM MAQUET CARDIOPULMONARY GMBH MCP00706291#ROTAFLOW PUMP MODULE 04037691718910

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown